NCT03511716

Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation

HRT Observational Study of a Mitral Bridge in Patients With Moderate to Severe Mitral Valve Regurgitation to Evaluate Device Safety and Performance

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: Heart Repair Technologies, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral regurgitation.

Detailed description

The primary objective of this study is to evaluate the safety and performance of the Mitral Bridge device in the correction of mitral valve regurgitation in patients who qualify for mitral valve repair as defined by the American Society of Echocardiography (ASE). The device is a single use, mitral valve implant designed to reduce mitral regurgitation by reducing the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane. The protocol was designed as a First In Man (FIM) with a 6-month follow up but was amended to follow the enrolled patients for a total of 5 years.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	HRT Mitral Bridge Mitral Valve Repair	Surgical mitral valve implant intended to reduce mitral regurgitation by direct reduction of the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane

Timeline

• Start date: 2014-02-06
• Primary completion: 2019-08-01
• Completion: 2019-08-31
• First posted: 2018-04-30
• Last updated: 2020-10-08

Locations

1 site across 1 country: Czechia